Cqv Manager

Directly responsible for the successful delivery of compliance projects to IPS clients Works with IPS CQV Project management team to develop and apply quality practices for all project deliverables and business practices In conjunction with the Project management team performs project audits to ensure all project goals are being met and compliance services are offered as a value-added product to IPS clients Promote efficiency in staff utilization Manages and assigns regional resources to meet project requirements Works with other Regional Managers and other IPS disciplines to maintain targeted budgeted utilization Tracks staff assignments makes resource projections and makes necessary adjustments as required Prepares workload forecasts to support staffing management Leads mentors trains and manage team of compliance staff assigned to the respective regional office Assists and mentors staff to set performance and career goals Provides routine feedback and conducts formal time-based performance reviews Implement corrective action plans as required Generates and performs C Q V deliverable activities audits and other compliance services as required to meet project requirements and personal billability goals Works with potential new and existing clients to initiate projects following current industry practices Performs strategic and master planning activities to assure projects are initiated started on the right foot Preparation of project monthly report Management of various GEP and GMP documents QMS Document review and Gap analysis Ensures the quality accuracy and completeness of overall work as to CQV Department compliance with established IPS and client standards procedures codes and ordinances Guidance for implementation of Biotech Pharmaceutical industry standards in generating and updating supporting documentation such as P IDs material and equipment specifications datasheets and user requirement specifications Track Quality deliverables by strong interaction with inhouse team clients vendors Qualifications Requirements Must be able to demonstrate competency in performing the responsibilities of a CQV Manager Bachelor s degree in engineering or a related field preferred A minimum of 10 years Manager to 15 years Director of experience in Pharmaceutical Biotech Medical Device Design Construction Commissioning Validation or QA Experience in writing and execution of PFC FC IQ OQ and PQ forms and protocols for GMP Utilities Equipment Systems and Software Experience with Cleaning Process Computer System Methods and other validation activities and processes Detailed experience in the discipline of GMP Validation with a knowledge and understanding of pharmaceutical Design Build Commission Validate processes and how they relate to regulatory requirements and cGMP regulations Progressive ability capacity and aptitude in administration to plan organize supervise and coordinate technical work and to obtain cooperation from others Analytical thinking structured problem-solving skills superior communications skills team building and strong work ethics Must be able to build rapport with department staff